Dr. David Kessler, a FDA author in the 1990s, while a powerful Opioid OxyContin Perdie was a powerful opioid drug, says the FDA should never have allowed drugs. The agency mistaken, radically expanding the market for opioids, despite the lack of research on safety and efficacy for long-term use, he says. A former commissioner said that the opioid label should be changed to limit the ability of pharmaceutical companies to spread opiates. "It needs to be done," he says.
Changes in the FDA designation for opioids, such as OxyContin for prolonged use, gave a great deal of pharmaceutical green light to push opiates to tens of millions of new patients across the country. "You have a pharmaceutical advancement system that has changed the way medicine is practiced, and no one, okay, did not stop it," says Kessler. Marketing has led to excessive use of dangerous drugs, and the river of tablets has fueled a deadly epidemic, as companies were allowed to sell more and more tablets at higher and higher doses. Kessler talks to Bill Whitaker in a 60-minute report to be broadcast on Sunday, February 24, at 7:00 pm ET / PT at CBS. OxyContin to be used for a long period of time & # 39; chronic pain suffers. Initially approved on the basis of science, which showed it safe and effective only with the use of "short-term", the label was changed without adequate scientific research. "We do not know if these drugs are safe and effective in chronic use," says Kesler. "The strict type of research that the agency must rely on does not exist." The right to market for a new indication eventually was given to a general class of opioids
Dr.. Andrew Kolodny, an addiction specialist at Brandeis University, is trying to change the label since 201
Asked by Whitaker, why the FDA failed to act in this case, as it was created by the watchman, Kessler partially accused the FDA's marketing and promotion department of work.
Dr. Scott Gottlieb, the current FDA commissar, rejected the request for an interview, but applied for 60 minutes. She partly says: "There have been many mistakes made on this path … Although the agency has adhered to the law on the approval and regulation of opioids, we in the FDA include ourselves among those who were supposed to act earlier."
On Sunday, 60 minutes, Whitaker will also report on the role that drug makers have in changing the labels that have significantly increased profits – and on the relationship between drug manufacturers and the FDA
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